Lecture 2 - EC Directive 178/2002 and SI 747 of 2007 PDF

EC Directive 178/2002 and SI 747 of 2007 European Communities (General Food Law) Regulations of 2007 Lecturer: Michael King Module Learning Outcomes The Learning Outcomes for this modules are 1: Describe the quality management systems for ingredients and components. 2: Identify the relevan...

EC Directive 178/2002 and SI 747 of 2007 European Communities (General Food Law) Regulations of 2007 Lecturer: Michael King Module Learning Outcomes The Learning Outcomes for this modules are 1: Describe the quality management systems for ingredients and components. 2: Identify the relevant EU regulatory, industrial and retailer standards in the food industry. 3: Define the legal implications of non- conformance 4: Describe the QC testing pathway in food manufacturing industry. 5: Comply with Food Hygiene standards Level 1 and Level 2 ©2020, Innopharma Labs Ltd and King Quality Solutions 2 Learning Outcomes – Lecture 2 After Tonight's Lecture 1. Identify the relevant EU regulatory, industrial and retailer standards in the food industry. 2: Define the legal implications of non- conformance ©2020, Innopharma Labs Ltd and King Quality Solutions 3 EC Directive 178/2002 – General principles of food law EC Regulation 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety contain the main legal requirement for consumer protection. The following sections need to be considered ©2020, Innopharma Labs Ltd and King Quality Solutions 4 EC Directive 178/2002 – Article 8 Protection of consumers' interests 1. Food law shall aim at the protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consume. It shall aim at the prevention of: (a) fraudulent or deceptive practices; (b) the adulteration of food; and (c) any other practices which may mislead the consumer ©2020, Innopharma Labs Ltd and King Quality Solutions 5 EC Directive 178/2002 – Article 14 1. Food shall not be placed on the market if it is unsafe. 2. Food shall be deemed to be unsafe if it is considered to be: (a) injurious to health; (b) unfit for human consumption. ©2020, Innopharma Labs Ltd and King Quality Solutions 6 EC Directive 178/2002 – Article 14 3. In determining whether any food is unsafe, regard shall be had: (a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and (b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods ©2020, Innopharma Labs Ltd and King Quality Solutions 7 EC Directive 178/2002 – Article 14 4. In determining whether any food is injurious to health, regard shall be had: (a) not only to the probable immediate and/or short-term and/or long-term effects of that food on the health of a person consuming it, but also on subsequent generations; (b) to the probable cumulative toxic effects; (c) to the particular health sensitivities of a specific category of consumers where the food is intended for that category of consumers. ©2020, Innopharma Labs Ltd and King Quality Solutions 8 EC Directive 178/2002 – Article 14 5. In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.. ©2020, Innopharma Labs Ltd and King Quality Solutions 9 EC Directive 178/2002 – Article 14 6. Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe 7. Food that complies with specific Community provisions governing food safety shall be deemed to be safe insofar as the aspects covered by the specific Community provisions are concerned. ©2020, Innopharma Labs Ltd and King Quality Solutions 10 EC Directive 178/2002 – Article 14 8. Conformity of a food with specific provisions applicable to that food shall not bar the competent authorities from taking appropriate measures to impose restrictions on it being placed on the market or to require its withdrawal from the market where there are reasons to suspect that, despite such conformity, the food is unsafe. ©2020, Innopharma Labs Ltd and King Quality Solutions 11 EC Directive 178/2002 – Article 16 Without prejudice to more specific provisions of food law, the labelling, advertising and presentation of food or feed, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, shall not mislead consumers. ©2020, Innopharma Labs Ltd and King Quality Solutions 12 EC Directive 178/2002 – Article 17 - Responsibility 1. Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met. 2. Member States shall enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution. ©2020, Innopharma Labs Ltd and King Quality Solutions 13 EC Directive 178/2002 – Article 17 - Responsibility For that purpose, they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution. Member States shall also lay down the rules on measures and penalties applicable to infringements of food and feed law. The measures and penalties provided for shall be effective, proportionate and dissuasive ©2020, Innopharma Labs Ltd and King Quality Solutions 14 EC Directive 178/2002 – Article 18 - Traceability 1. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution. 2. Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food- producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed. ©2020, Innopharma Labs Ltd and King Quality Solutions 15 EC Directive 178/2002 – Article 18 - Traceability To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand. 3. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand. ©2020, Innopharma Labs Ltd and King Quality Solutions 16 EC Directive 178/2002 – Article 18 - Traceability 4. Food or feed which is placed on the market or is likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions. 5. Provisions for the purpose of applying the requirements of this Article in respect of specific sectors may be adopted in accordance with the procedure laid down in Article 58(2). ©2020, Innopharma Labs Ltd and King Quality Solutions 17 EC Directive 178/2002 – Article 19 – Responsibility for food – Food Business Operator 1. If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection. ©2020, Innopharma Labs Ltd and King Quality Solutions 18 EC Directive 178/2002 – Article 19 – Responsibility for food – Food Business Operator 2. A food business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the food-safety requirements and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities. ©2020, Innopharma Labs Ltd and King Quality Solutions 19 EC Directive 178/2002 – Article 19 – Responsibility for food – Food Business Operator 3. A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health. Operators shall inform the competent authorities of the action taken to prevent risks to the final consumer and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food. ©2020, Innopharma Labs Ltd and King Quality Solutions 20 EC Directive 178/2002 – Article 19 – Responsibility for food – Food Business Operator 4. Food business operators shall collaborate with the competent authorities on action taken to avoid or reduce risks posed by a food which they supply or have supplied. Note – Article 20 places similar requirements of feed producers ©2020, Innopharma Labs Ltd and King Quality Solutions 21 SI 747 of 2007 – Part 2 3. The Minister may, for the purposes of these Regulations designate, by notice in writing published (a) a laboratory as a laboratory at which samples taken under these Regulations may be analysed, or (b) a person as being a person who, or a class of persons the members of which, may, at a designated laboratory, engage in analysis for the purposes of these Regulations and complete certificates in the form set out in Schedule 1. ©2020, Innopharma Labs Ltd and King Quality Solutions 22 SI 747 of 2007 – Part 2 4. (1) These Regulations shall not apply to food businesses engaged in activities which are subject to— (a) the European Communities (Food and Feed Hygiene) Regulations 2005 ( S.I. No. 910 of 2005 ), or (b) the European Communities (Hygiene of Fishery Products and Fish Feed) Regulations 2006 ( S.I. No. 335 of 2006 ), only to the extent that the food business engages in those activities. ©2020, Innopharma Labs Ltd and King Quality Solutions 23 SI 747 of 2007 – Part 2 (2) The competent authority for the purposes of the relevant provisions of the EC Regulation, and for the purposes of these Regulations shall be— (a) the Authority, or (b) the official agency where these Regulations provide for the execution of a competent authority function under the ©2020, Innopharma Labs Ltd and King Quality Solutions 24 SI 747 of 2007 – Part 2 (3) The public authority for the purposes of Article 10 of the EC Regulation, and for the purposes of these Regulations, shall be the Authority or the official agency, as appropriate. 5. (1) A food business operator is guilty of an offence if the food business operator places unsafe food on the market or otherwise contravenes Article 14 of the EC Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 25 SI 747 of 2007 – Part 2 2) Where the Authority or the official agency suspects that food is unsafe, although it conforms with specific provisions applicable to that food, the Authority, or the official agency, may take appropriate measures to impose restrictions on such food being placed on the market, or require its withdrawal from the market, in accordance with Article 14 of the EC Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 26 SI 747 of 2007 – Part 2 (3) In proceedings for an offence under paragraph (1), it is a defence for a person charged with the offence to prove both of the following— (a) commission of the offence was due to a mistake or the reliance on information supplied to him or her, or to the act or default of another person, an accident or some other cause beyond his or her control, and (b) he or she exercised due diligence and took all reasonable precautions to avoid commission ofInnopharma ©2020, the offence. Labs Ltd and King Quality Solutions 27 SI 747 of 2007 – Part 2 (4) If reliance on the defence provided by paragraph (3) involves the allegation that the commission of the offence was due to reliance on information supplied by another person or to the act or default of another person, the person charged with the offence shall not, without leave of the court, be entitled to rely on that defence unless, not less than 7 working days before the hearing, he or she has served on the prosecutor written notice providing information identifying, or assisting in the identification of, that other person. ©2020, Innopharma Labs Ltd and King Quality Solutions 28 SI 747 of 2007 – Part 2 6. A food business operator is guilty of an offence if the food business operator fails to comply with Article 16 of the EC Regulation in the labelling, advertising or presentation of food. 7. A food business operator is guilty of an offence if— (a) the food business operator fails to ensure (in accordance with Article 17 of the EC Regulation) that a food satisfies the relevant requirements of food law, or ©2020, (b)Innopharma the food business Labs Ltd and operator fails to carry out King Quality Solutions 29 SI 747 of 2007 – Part 2 8. A food business operator is guilty of an offence if the food business operator fails– (a) to identify a person who has supplied the food business operator with food, (b) to identify another business to which the food business operator has supplied food, (c) to have in place systems and procedures (including documentation) which allow for information on provenance and destination of foods to be made available to the official agency on demand ©2020, Innopharma Labs Ltd and King Quality Solutions 30 SI 747 of 2007 – Part 2 (d) to provide the official agency with information on provenance or destination of a food, on demand (e) to adequately label or identify food for the purposes of traceability, through relevant documentation or information, (f) to maintain records in accordance with Schedule 2, (g) to maintain records for the duration prescribed in Schedule 2, or (h) in any other way to comply with Article 18 ofInnopharma ©2020, the EC LabsRegulation Ltd and King Quality Solutions 31 SI 747 of 2007 – Part 2 9. (1) A food business operator is guilty of an offence if the food business operator fails to— (a) initiate procedures to withdraw a food, (b) ensure that a food is withdrawn, (c) inform the Authority or the official agency of the initiation of procedures to withdraw a food, (d) effectively and accurately inform consumers of the reasons for withdrawal of a food, or (e) recall products from consumers, in accordance with Article 19(1) of the EC Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 32 SI 747 of 2007 – Part 2 (2) A food business operator responsible for retail or distribution activities that do not affect the packaging, labelling, safety or integrity of a food, is guilty of an offence, if the food business operator fails to— (a) initiate procedures to withdraw a food, (b) ensure that a food is withdrawn, (c) pass on relevant information necessary to trace a food, or (d) cooperate in action taken by producers, processors, manufacturers, and/or the Authority or the official agency, in accordance with Article ©2020, Innopharma Labs Ltd and King Quality Solutions 33 SI 747 of 2007 – Part 2 (3) A food business operator is guilty of an offence if the food business operator— (a) fails to immediately inform the Authority or the official agency of any grounds for believing that a food which it has placed on the market may be injurious to human health, (b) fails to inform the Authority or the official agency of the action taken to prevent risks to the final consumer, or (c) prevents or discourages any person from cooperating with the Authority or the official agency, in accordance with Article 19(3) of the ©2020, Innopharma Labs Ltd and King Quality Solutions 34 EC Regulation. SI 747 of 2007 – Part 2 (4) A food business operator is guilty of an offence if the food business operator fails or refuses to collaborate with the Authority or the official agency, or both, on action taken to avoid or reduce risks posed by a food, in accordance with Article 19(4) of the EC Regulation. (5) A food business operator is guilty of an offence if the food business operator fails in any other way to respond to an actual or potential breach of food safety requirements in accordance with the provisions of Article 19 of the EC Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 35 SI 747 of 2007 – Part 2 (6) Where the Authority or the official agency forms the view that a food business operator should be taking measures pursuant to Article 19, but is failing to do so, the Authority, or the official agency, or both, may take action pursuant to Regulation 20. 10. (1) A food business operator is guilty of an offence if the food business operator exports or re-exports food which does not comply with the relevant requirements of food law, unless the non-compliance is permitted in accordance with Article 12 of the EC Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 36 SI 747 of 2007 – Part 2 (2) A food business operator exporting or re- exporting food which does not comply with the relevant requirements of food law is not guilty of any offence under these Regulations or under other food law, if the non-compliance is permitted in accordance with Article 12 of the EC Regulation. 11. The Minister, after consultation with the Authority, and taking account of the precautionary principle set out in Article 7 of the EC Regulation, may, by order, put in place interim protective measures with regard to food, asInnopharma ©2020, provided Labs Ltdfor inQuality and King Article 54 of the EC Regulation. Solutions 37 SI 747 of 2007 – Part 3 Enforcement 2. (1) The enforcement of these Regulations and of the relevant provisions of the EC Regulation, shall be carried out in accordance with the provisions of these Regulations. (2) These Regulations shall be deemed to be food legislation for the purposes of the Act of 1998. ©2020, Innopharma Labs Ltd and King Quality Solutions 38 SI 747 of 2007 – Part 3 Enforcement (3) These Regulations and the relevant provisions of the EC Regulation shall be enforced by the Authority or by the official agency acting pursuant to a service contract with the Authority and, without prejudice to paragraph (1), the enforcement provisions contained in the Act of 1998 shall apply for the purpose of ensuring compliance with the requirements of these Regulations and with the relevant provisions of the EC Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 39 SI 747 of 2007 – Part 3 Enforcement 13. An authorised officer may, for the purposes of these Regulations, and for the purposes of enforcing the relevant provisions of the EC Regulation, at all reasonable times and subject to Section 50 of the Act of 1998, enter any premises in which he or she has reasonable grounds for believing that any food is being produced, manufactured, imported, processed, stored, transported, distributed or traded, and do all or any of the following— (a) take the reading of values recorded by measuring instruments installed on the premises, (b) make such other examinations, tests and ©2020, Innopharma Labs Ltd and King Quality Solutions 40 SI 747 of 2007 – Part 3 Enforcement (c) there, or at any other place, interview the food business operator concerned or any relevant staff, (d) require the food business operator or any relevant staff to produce any documents and to provide such assistance and information in relation to the documents as may be necessary, or (e) inspect and take copies or extracts from records (including, in the case of information in a non- legible form, a copy of or an extract from such information in a legible form). ©2020, Innopharma Labs Ltd and King Quality Solutions 41 SI 747 of 2007 – Part 3 Enforcement 14. (1) An authorised officer may, for the purposes of these Regulations and for the purposes of enforcing the relevant provisions of the EC Regulation, purchase or take without payment a sample of a food. (2) An authorised officer may, for the purpose of taking a sample of a food, open any receptacle. (3) Where an authorised officer purchases or takes without payment a sample of a food with the intention of having it analysed, he or she shall, after purchasing or taking the sample, forthwith notify the food business operator, or the person in apparent charge or control of such food, of his or ©2020, Innopharma Labs Ltd and King Quality Solutions 42 SI 747 of 2007 – Part 3 Enforcement 4) Where an authorised officer purchases or takes without payment, with the intention of having it analysed, a sample of a food, which is suspected by him or her— (a) to be unsafe, or (b) to fail to comply with the provisions of these or any other Regulations applicable to such a food, or with the relevant provisions of the EC Regulation, ©2020, Innopharma Labs Ltd and King Quality Solutions 43 SI 747 of 2007 – Part 3 Enforcement he or she may, by notice in writing to the food business operator, or person in apparent charge or control of such food, prohibit the removal of the food except to any place which may be specified in the notice, during such period as may be specified in the notice, but not exceeding 15 days from the date of the taking of the sample. ©2020, Innopharma Labs Ltd and King Quality Solutions 44 SI 747 of 2007 – Part 3 Enforcement 15. (1) Where a sample of a food is taken pursuant to these Regulations for the purpose of official analysis, and where the division of the sample is reasonably practicable, the authorised officer concerned may divide the sample into three approximately equal parts (enforcement, trade (defence) and referee), each of which he or she shall mark in such a way as to identify it as a part of the sample taken. The authorised officer shall, in the presence of the ©2020, foodLabsbusiness Innopharma operator, Ltd and King Quality Solutions or person in 45 SI 747 of 2007 – Part 3 Enforcement a) mark, seal and fasten each part in such a manner as its nature will permit, and in such a way that the integrity of the sample is not compromised; (b) forward one part to the approved examiner in an official laboratory for analysis; (c) give or send one part to the food business operator, and (d) retain the third part. ©2020, Innopharma Labs Ltd and King Quality Solutions 46 SI 747 of 2007 – Part 3 Enforcement (2) Where an authorised officer takes, for the purposes of official analysis, a sample consisting of food contained in unopened containers and its division into parts— (a) is not reasonably practicable, or (b) might affect the composition or impede the proper analysis of the sample, the provisions of paragraph (1) as regards the division of samples into parts shall be deemed to be complied with if the authorised officer divides the containers into three lots and deals with ©2020, each Innopharma Labs lot as Ltd and Kingif it were Quality Solutions a sample as specified 47 SI 747 of 2007 – Part 3 Enforcement 3) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or report on a sample of, a food taken pursuant to these Regulations, shall not be adduced unless before the proceedings were instituted the sample was divided as specified in paragraphs (1) and (2). The part, package or container retained by the authorised officer shall be produced at the hearing. ©2020, Innopharma Labs Ltd and King Quality Solutions 48 SI 747 of 2007 – Part 3 Enforcement 16. (1) The approved examiner or a person under his or her direction shall analyse as soon as possible any sample of a food submitted to him or her in pursuance of these Regulations and the approved examiner shall certify to the person who submitted the sample to him or her, the result of such analysis. The form of certificate set out in Schedule 1 or a certificate in like form shall be used. (2) An official certificate given in accordance with ©2020, paragraph Innopharma Labs Ltd and King (1) Qualityshall Solutions be prima facie 49 SI 747 of 2007 – Part 3 Enforcement 17. Where a sample of a food is taken by an authorised officer in pursuance of these Regulations for analysis by an approved examiner, the Authority, or the official agency, as the case may be, shall draw up a report in accordance with Article 9 of the Official Controls Regulation, and where the certificate given in accordance with Regulation 16 indicates that there has been non-compliance with the relevant provisions of the EC Regulation, the Authority or the official agency, as the case ©2020, Innopharma Labs Ltd and King Quality Solutions 50 SI 747 of 2007 – Part 3 Enforcement 8. (1) An authorised officer may, for the purposes of these Regulations and the relevant provisions of the EC Regulation, inspect and take copies, or samples, of— (a) labels used on food, (b) packaging of a food, or (c) any other materials used in the advertising or presentation of food. ©2020, Innopharma Labs Ltd and King Quality Solutions 51 SI 747 of 2007 – Part 3 Enforcement 2) An authorised officer may request a food business operator to produce the information referred to in Article 18 of the EC Regulation and he or she may inspect, and take copies of, any such information. ©2020, Innopharma Labs Ltd and King Quality Solutions 52 SI 747 of 2007 – Part 3 Enforcement 19. (1) An authorised officer may, for the purposes of these Regulations, seize, remove, detain or direct the withdrawal from the market of any food where he or she suspects that the food fails to comply with the relevant provisions of the EC Regulation, or where a food business operator has failed to take measures pursuant to Article 19 of the EC Regulation, which in the view of the Authority or the official agency, or both, should have been taken ©2020, Innopharma Labs Ltd and King Quality Solutions 53 SI 747 of 2007 – Part 3 Enforcement 2) An authorised officer may, with the consent in writing of the food business operator, or in accordance with an order of a judge of the District Court under paragraph (4), destroy or otherwise dispose of a food so as to prevent the food being used for human consumption. ©2020, Innopharma Labs Ltd and King Quality Solutions 54 SI 747 of 2007 – Part 3 Enforcement (3) An authorised officer who has seized, removed, detained or directed the withdrawal from the market of a food in pursuance of the provisions of this Regulation may, on giving notice in writing to the food business operator of his or her intention to do so, apply to a judge of the District Court for an order directing that such food be destroyed or otherwise disposed of ©2020, Innopharma Labs Ltd and King Quality Solutions 55 SI 747 of 2007 – Part 3 Enforcement (4) A judge of the District Court, to whom an application is made for an order under paragraph (3), may, if satisfied that— (a) such food fails to comply with the relevant provisions of the EC Regulation, or (b) the food business operator has failed to take measures in respect of the food which it ought to have taken pursuant to Article 19 of the EC Regulation, ©2020, Innopharma Labs Ltd and King Quality Solutions 56 SI 747 of 2007 – Part 3 Enforcement 20. (1) A food business operator, or the owner or person in charge of the premises and any person employed there shall– (a) afford to an authorised officer such facilities and assistance as are reasonably necessary to enable the officer to perform his or her functions under these Regulations and under the relevant provisions of the EC Regulation, (b) produce to an authorised officer any books, documents, computerised data, written material as to verification systems or other records ©2020, which Innopharma Labs heQuality Ltd and King or she Solutionsmay reasonably 57 SI 747 of 2007 – Part 3 Enforcement c) give to an authorised officer any information which he or she may reasonably require regarding— (i) any food on the premises, (ii) any books, documents, computerised data, or written material as to verification systems or other records produced by him or her pursuant to these Regulations, or (iii) the composition of any food. ©2020, Innopharma Labs Ltd and King Quality Solutions 58 SI 747 of 2007 – Part 3 Enforcement (2) An authorised officer, when exercising any powers under these Regulations, may be accompanied by other persons and may take with him or her, or those persons may take with them, any equipment or materials necessary to assist the officer in the exercise of those powers ©2020, Innopharma Labs Ltd and King Quality Solutions 59 SI 747 of 2007 – Part 3 Enforcement 21. Where an authorised officer has reasonable grounds for believing that a person has contravened any provision of these Regulations or any relevant provision of the EC Regulation, and so informs that person, the authorised officer may require that person to state his or her name and address and, if the authorised officer thinks it necessary, to produce corroborative evidence of same. ©2020, Innopharma Labs Ltd and King Quality Solutions 60 SI 747 of 2007 – Part 3 Enforcement 22. (1) A person is guilty of an offence if he or she fails to comply with these Regulations, or with the relevant provisions of the EC Regulation. (2) Paragraph (1) shall not apply to an authorised officer or an approved examiner acting in the course of his or her duties pursuant to these Regulations. (3) A person is guilty of an offence if he or she —Innopharma Labs Ltd and King Quality Solutions ©2020, 61 SI 747 of 2007 – Part 3 Enforcement (a) obstructs or interferes with an authorised officer in the exercise of the officer’s powers under these Regulations, (b) fails or refuses to state his or her name or address in compliance with a request under these Regulations, (c) fails to comply with a request or notice from an authorised officer under these Regulations, (d) makes a statement to an authorised officer which the person knows is false or misleading, or (e) gives in purported compliance with a request under these Regulations a name, address or ©2020, Innopharma Labs Ltd and King Quality Solutions 62 SI 747 of 2007 – Part 3 Enforcement 23. Where an offence under these Regulations is committed by a body corporate or by a person acting on behalf of a body corporate and is proved to have been so committed with the consent, connivance or approval of, or to be attributed to any neglect or default on the part of, any director, manager, secretary or any other officer of such body, or a person who was purporting to act in any such capacity, such person is also guilty of an offence and is liable to be proceeded against and punished asInnopharma ©2020, if he Labs or Ltdshe were and King guilty of the first- Quality Solutions 63 SI 747 of 2007 – Part 3 Enforcement 24. (1) A person is guilty of an offence if he or she forges, or utters knowing it to be forged, a certificate of analysis or other document purporting to be issued, granted or given under these Regulations, or required for the purposes of these Regulations (hereafter in this Regulation referred to as “a forged document”). (2) A person is guilty of an offence if he or she alters with intent to defraud or deceive, or utters knowing it to be so altered, a certificate of analysis or other document issued, ©2020, granted Innopharma Labs or given Ltd and King Quality Solutions under these 64 SI 747 of 2007 – Part 3 Enforcement (3) A person is guilty of an offence if he or she, without lawful authority, has in his or her possession a forged document or an altered document, knowing it to be a forged or altered document as the case may be. (4) A person is guilty of an offence if he or she, with intent to defraud or deceive— (a) tampers with any substance or thing with the result that a sample taken pursuant to these Regulations does not correctly represent the substance sampled, or (b) tampers or interferes with any sample ©2020, Innopharma Labs Ltd and King Quality Solutions 65 taken under these Regulations. SI 747 of 2007 – Part 3 Enforcement (5) A person is guilty of an offence if he or she falsely represents himself or herself to be an authorised officer. 25. (1) For the purposes of these Regulations, every contravention of a Regulation shall be deemed a separate contravention and every contravention of a paragraph or a subparagraph shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of ©2020, Innopharma Labs Ltd and King Quality Solutions 66 SI 747 of 2007 – Part 3 Enforcement (2) For the purposes of these Regulations, every contravention of any of the relevant provisions shall be deemed a separate contravention, and every contravention of a paragraph or subparagraph of these Articles shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any Regulation of these Regulations. (3) A person who is guilty of an offence under these Regulations is liable— ©2020, Innopharma Labs Ltd and King Quality Solutions 67 SI 747 of 2007 – Part 3 Enforcement (a) on summary conviction, to a fine not exceeding €5,000, or imprisonment for a term not exceeding 3 months, or both, or, (b) on conviction on indictment, to a fine not exceeding €500,000, or imprisonment for a term not exceeding 3 years, or both. ©2020, Innopharma Labs Ltd and King Quality Solutions 68 SI 747 of 2007 – Part 3 Enforcement 26. Notwithstanding Section 57 of the Act of 1998, a summary offence under these Regulations may be prosecuted by— (a) the Authority, or (b) the official agency, or both. ©2020, Innopharma Labs Ltd and King Quality Solutions 69